Irradiated Donor Lymphocyte Infusion Plus High-dose IL-2

Phase II Study of Irradiated Donor Lymphocyte Infusion Plus High-dose Interleukin-2 in Patients With Metastatic Malignant Melanoma and Renal Cell Carcinoma

Partially HLA-matched irradiated donor lymphcyte infusion alone resulted in 27% overall response rate (ORR) in advanced renal cell carcinoma without significant toxicities. In addition, high-dose interleukin-2 (IL-2)showed an ORR of 6-21% in metastatic melanoma or renal cell carcinoma with a durable response in patients who achieved complete remission. Therefore, irradiated donor lymphocyte infusion plus high-dose IL-2 might show a synergistic anti-tumor activity agaist relapsed or metastatic melanoma or renal cell carcinoma.

Inclusion Criteria:

• Histologically confirmed malignant melanoma or renal cell carcinoma
• At stage IV or relapse
• At least one prior chemotherapy including targeted agents
• At least one haploidential or partially matched-HLA donor
• ECOG performance status 0-1
• Age 18-75 years
• Measurable lesion
• Adequate bone marrow, liver, and renal functions

Exclusion Criteria:

• Chemotherapy within 4 weeks
• Stem cell transplantation
• Active CNS metastasis
• Hypersensitivity to IL-2